A study of Rehabilitation in patients taking part in the Operated Lung Cancer Programme in comparison to the non intervention group
| ISRCTN | ISRCTN00061628 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00061628 |
| Protocol serial number | 9448 |
| Sponsor | Heart of England NHS Foundation Trust |
| Funder | The Health Foundation (UK) |
- Submission date
- 27/05/2011
- Registration date
- 27/05/2011
- Last edited
- 25/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Miss Amy Bradley
Scientific
Scientific
Critical Care MIDRU
Birmingham Heartlands Hospital
Bordersley Green East
Birmingham
B9 5SS
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised interventional and Observational qualitative trial |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A study of rehabilitation in patients taking part in the operated lung cancer programme in comparison to the non intervention group |
| Study acronym | ROC |
| Study objectives | The study aims to examine whether a rehabilitation programme that identifies potential surgical candidates several weeks before surgery and optimises their physical status, prepare them for the inpatient journey and support their recovery after surgery, reduces: 1. In patient length of stay 2. Reduced rate of Pulmonary Complication (PPC) 3. Reduced ITU and HDU admissions 4. Increased patient quality of life 5. Deliver cost savings |
| Ethics approval(s) | First MREC approval date 21/07/2010, ref 10/H1208/41 |
| Health condition(s) or problem(s) studied | Lung cancer (small cell & non-small cell) |
| Intervention | 1. Rehabilitation for Operated lung Cancer (ROC) programme 2. Pulmonary rehabilitation 3. Smoking cessation 4. Dietary advice 5. Patient self-management 6. Follow up length: 5 month(s) 7. Study entry: registration only |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Reduced inpatient length of stay |
| Key secondary outcome measure(s) |
1. Increased patient quality of life, timepoint(s): 5 months from surgery |
| Completion date | 01/04/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 1275 |
| Key inclusion criteria | 1. All Patients undergoing curative lung resections for lung cancer 2. Patients that are equal to 18 years old or over 3. Patients willing to give consent 4. Patients treated by Heart of England Foundation NHS Trust (Heartlands and Solihull Hospital not Good Hope Hospital 5. Patients treated by Worcestershire Acute Hospitals Trust (Worcester Royal Hospital) 6. Target gender: male & female 7. Lower age limit 18 years |
| Key exclusion criteria | Patients referred from 1. Heart of England Foundation NHS Trust, Good Hope Hospital 2. Worcestershire Acute Hospitals NHS Trust, Redditch Hospital 3. University Hospitals Birmingham Foundation NHS Trust 4. Sandwell and West Birmingham Hospitals NHS Trust 5. Gloucestershire Hospitals NHS Foundation NHS Trust 6. Hereford Hospital NHS Trust 7. Walsall Hospitals NHS Trust |
| Date of first enrolment | 01/04/2011 |
| Date of final enrolment | 01/04/2016 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Critical Care MIDRU
Birmingham
B9 5SS
United Kingdom
B9 5SS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2013 | Yes | No | |
| Results article | results | 01/05/2019 | 25/02/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/02/2019: Publication reference added.
